Octreotide Acetate Injection 500mcg/ml (Prostatin)

GENERIC NAME OF THE MEDICINAL PRODUCT:

A. Octreotide Acetate Injection 50mcg/1ml
B. Octreotide Acetate Injection 100mcg/1ml
C. Octreotide Acetate Injection 500mcg/1ml
D. Octreotide Acetate Injection 1000mcg/5ml
E. Octreotide Acetate Injection 5000mcg/5ml

QUALITATIVE AND QUANTITATIVE COMPOSITION:

1. Octreotide Acetate Injection 50mcg/1ml
Each ml contains:
Octreotide Acetate USP
Equivalent to Octreotide …………50mcg
Water for Injection USP……………q.s
*No preservative

2. Octreotide Acetate Injection 100mcg/1ml
Each ml contains:
Octreotide Acetate USP
Equivalent to Octreotide …………100mcg
Water for Injection USP…………….q.s
*No preservative

3. Octreotide Acetate Injection 500mcg/1ml
Each ml contains:
Octreotide Acetate USP
Equivalent to Octreotide …………500mcg
Water for Injection USP…………….q.s
*No preservative

4. Octreotide Acetate Injection 1000mcg/5ml
Each ml contains:
Octreotide Acetate USP
Equivalent to Octreotide …………200mcg
Water for Injection USP……………q.s

5. Octreotide Acetate Injection 5000mcg/5ml
Each ml contains:
Octreotide Acetate USP
Equivalent to Octreotide …………1000mcg
Water for Injection USP………q.s

THERAPEUTIC INDICATIONS:

Octreotide injection is used to treat severe diarrhea and other symptoms that occur with certain intestinal tumors (eg, vasoactive intestinal peptide tumors or VIPomas) or metastatic carcinoid tumors (tumors that has already spread in the body).

DIRECTION OF USE:

For Subcutaneous or Intravenous use only.
See packaging inserts for full prescribing information. /

CAUTION & WARNING:

CAUTION: Do not use if any foreign particulate matter is visible and ask for replacement.
Discard unused portion.
Improper storage may deteriorate the product.
KEEP OUT OF REACH AND SIGHT OF CHILDREN.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.
Warning: Not to be sold by retail without the prescription of a Registered Medical Practitioner.

STORAGE & DOSAGE:

Storage: Store refrigerated between 2°C to 8°C (36°F to 46°F).
Protect from light.
Do not freeze.
Dosage: As directed by the Physician.

Octreotide Acetate Injection 500mcg/ml Technical Specification:

Product Name:Octreotide Acetate Injection
Brand Name:Prostatin
Strength:50mcg/ml, 100mcg/ml, 500mcg/ml, 1000mcg/5ml, 5000mcg/5ml
Dosage Form:Liquid Injection
Packing:50mcg/ml (1ml Single Dose Vial/Ampoule)
100mcg/ml (1ml Single Dose Vial/Ampoule)
500mcg/ml (1ml Single Dose Vial/Ampoule)
1000mcg/5ml (5ml Multiple Dose Vial)
5000mcg/5ml (5ml Multiple Dose Vial)
Route of Administration:For Subcutaneous or I.V. use only.
Pack Insert/Leaflet:PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics)
Regulatory Documents:COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier
Therapeutic use:Octapeptides,  Growth hormone inhibitor,  Anti-diarrheal
Indication: Octreotide injection is used to treat severe diarrhea and other symptoms that occur with certain intestinal tumors (eg, vasoactive intestinal peptide tumors or VIPomas) or metastatic carcinoid tumors (tumors that has already spread in the body).
Storage:Store refrigerated between 2°C to 8°C (36°F to 46°F). Protect from light. Do not freeze.

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Octreotide Acetate Injection 500mcg/ml (Prostatin)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

Octreotide Acetate Injection 500mcg/ml
Each ml contains:
Octreotide Acetate USP
Equivalent to Octreotide ….…500mcg
Water for Injection USP………q.s
*No preservative

THERAPEUTIC INDICATIONS:

Octreotide injection is used to treat severe diarrhea and other symptoms that occur with certain intestinal tumors (eg, vasoactive intestinal peptide tumors or VIPomas) or metastatic carcinoid tumors (tumors that has already spread in the body).

DIRECTION OF USE:

For Subcutaneous or Intravenous use only.
See packaging inserts for full prescribing information.

CAUTION & WARNING:

CAUTION: Do not use if any foreign particulate matter is visible and ask for replacement.
Discard unused portion.
Improper storage may deteriorate the product.
KEEP OUT OF REACH AND SIGHT OF CHILDREN.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.

Warning: Not to be sold by retail without the prescription of a Registered Medical Practitioner.

STORAGE & DOSAGE:

Storage: Store refrigerated between 2°C to 8°C (36°F to 46°F).
Protect from light.
Do not freeze.

Dosage: As directed by the Physician.